Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2022
Event Type  malfunction  
Event Description
It was reported that gasfilter connection was disconnected / broken.The failure was detected after unpacking product.Since there was not another product on the hospital to change the failed one, customer used the product on patient.Customer cut out the broken connector and gasfilter.Customer states that there was not any leakage occurred during treatment and no harm to any person has been reported.Trackwise # (b)(4).
 
Manufacturer Narrative
A follow up medwatch will be submitted when further information becomes available.
 
Event Description
Trackwise complaint # (b)(4).
 
Manufacturer Narrative
It was reported that gasfilter connection was disconnected / broken.The failure was detected after unpacking product.Since there was not another product on the hospital to change the failed one, customer used the product on patient.Customer cut out the broken connector and gasfilter.Customer states that there was not any leakage occurred during treatment and no harm to any person has been reported.Sample investigation could not be performed since the product was discarded by customer.Customer did not provide the lot number of the affected product.However, the photograph was received which shows the reported failure, broken / disconnected connection of gasfilter.Based on this, failure could be confirmed.In addition customer stated that velcro tab which secures oxygenator seems to be loose.However neither damage on products were reported nor picture was provided.Besides, there was not any abnormalities were reported for oxygenator, thus the loose velcro tab could not be confirmed.Therefore the most probable root cause could not be determined.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
 
Event Description
Trackwise complaint (b)(4).
 
Manufacturer Narrative
It was reported that gasfilter connection was disconnected / broken.The failure was detected after unpacking product.Since there was not another product on the hospital to change the failed one, customer used the product on patient.Customer cut out the broken connector and gasfilter.Customer states that there was not any leakage occurred during treatment and no harm to any person has been reported.Sample investigation could not be performed since the product was discarded by customer.Customer did not provide the lot number of the affected product.However, the photograph was received which shows the reported failure, broken / disconnected connection of gasfilter.Based on this, failure could be confirmed.In addition customer stated that velco tab which secures oxygenator seems to be loose.However neither damage on products were reported nor picture was provided.Besides, there was not any abnormalities were reported for oxygenator, thus the the loose velco tab could not be confirmed.Exact root cause could not be determined.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : sample was discarded by user.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TUBING SETS
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key16119830
MDR Text Key308162203
Report Number8010762-2023-00007
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K080592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient SexPrefer Not To Disclose
-
-